Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate

Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE. It is labelled by Softgel Healthcare Private Limited taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 35916-0185, application M012, label effective 20260427. It is one of 2 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE are most often described in connection with: temporarily relieves, common cold, flu symptoms, cough due, minor throat, bronchial irritation, aches pains, headache fever. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing

Directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take more than 8 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persists for more than 2 days,is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

FDA lists 2 drug label records with ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate used for?
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing

Who makes Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate?
Softgel Healthcare Private Limited is the labeler of record for Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate. 2 FDA label records share the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE?
Yes. 2 FDA drug label records list ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.